Biogen Idec, Inc. (BIIB), a developer of therapies to treat neurodegenerative diseases, hemophilia and autoimmune disorders, Monday said Health Canada has approved Alprolix for control and prevention of bleeding episodes and routine prophylaxis in both adults and children aged 12 or older who have hemophilia B.
The approval is based on the results of the Phase 3 B-Long study which demonstrated that Alprolix effectively prevented or reduced bleeding episodes with prophylactic infusions given once weekly or once every 10 to 14 days in adults and adolescents with severe hemophilia B. The company also said a single Alprolix infusion controlled more than 90 percent of all bleeding episodes in the study.
Biogen Idec said this is the first regulatory approval for Alprolix and it is in review in several countries including U.S., Australia and Japan. The company also noted that Alprolix is the first, long-acting, fully recombinant clotting factor therapy.
Hemophilia B is a rare, chronic and inherited disorder that impairs the ability of blood to clot due to a substantial reduction of, or no factor IX activity, leading to recurrent and extended bleeding episodes in the patient.
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